A Phase 1/2 interventional study of radiolabeled DPTA-omburtamab in Leptomeningeal Metastasis and Solid Tumor, Adult, sponsored by Y-mAbs Therapeutics. Withdrawn at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Y-mAbs Therapeutics · Phase 1/2, Interventional, and Treatment
Adults with leptomeningeal metastasis from solid tumors will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.
Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of five 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab.
Part 2 is a cohort-expansion phase in which patients will receive a treatment at the recommended dose determined in Part 1, until confirmed LM progression, unacceptable toxicity, or for maximum of 5 cycles, whichever comes first; however, the total number of cycles will be determined based upon data from Part 1 (e.g., the dosimetry data) to minimize the risk of radiation necrosis and decreased neurological function End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up until one year after first dose (Part 1) and 2 years after first dose (Part 2).
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Exclusion Criteria:
Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to five cycles.
Biological: radiolabeled DPTA-omburtamab
Biological, radiolabeled DPTA-omburtamab
Also known as: Drug: 177Lu-DTPA-omburtamab
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE version 5.0. The maximum tolerated dose and the recommended phase 2 dose (RP2D) will be determined in Part 1
Time frame: 1 year
Incidence of AEs and SAEs
In Part 2, safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE version 5.0, at the RP2D defined in Part 1
Time frame: 2 years
Maximum radioactivity count of lutetium-177 in blood
The time for maximum absorbed radiation dose
Time frame: 2 weeks
Elimination half-life of lutetium-177 radioactivity in blood
The time for eliminating half of the radioactivity in blood
Time frame: 2 weeks
Absorbed radiation dose of lutetium-177 in blood and cerebrospinal fluid (CSF)
Time-activity curves of radioactivity measurements in blood and CSF will be modeled to deliver absorbed doses in blood and CSF
Time frame: 2 weeks
Dosimetry analysis of lutetium-177
Whole-body dosimetry by gamma camera scans and single-photon emission computed tomography (SPECT)
Time frame: 2 weeks
Maximum Plasma Concentration [Cmax] in CSF
Concentration of 177Lu-DTPA-omburtamab in CSF
Time frame: 7 weeks
Maximum Plasma Concentration [Cmax] in serum
Concentration of 177Lu-DTPA-omburtamab in serum
Time frame: 7 weeks
Elimination Half Life in CSF
Concentration of 177Lu-DTPA-omburtamab in CSF
Time frame: 7 weeks
Elimination Half Life in serum
Concentration of 177Lu-DTPA-omburtamab in serum
Time frame: 7 weeks
Response
Objective response rate (ORR) will be defined as the proportion of all evaluable patients achieving a response as the best overall response at the time of assessment
Time frame: 2 years
Investigator-assessed Duration of Response (DoR)
DoR is defined as the time from first response to LM progression
Time frame: 2 years
Progression-free Survival (PFS)
PFS is defined as the time from first treatment to date of LM progression or death from any cause, whichever comes first
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from first treatment to date of death
Time frame: 2 years
Plan to share: Undecided
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This study is withdrawn, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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